US approves combination of Johnson & Johnson, Genmab's Darzalex plus Revlimid, dexamethasone for newly diagnosed multiple myeloma

The FDA has expanded the indication for Johnson & Johnson and Genmab's Darzalex (daratumumab) to include its use in combination with Celgene's Revlimid (lenalidomide) and dexamethasone for the first-line treatment of multiple myeloma in patients who are not eligible for autologous stem cell transplant (ASCT), the companies announced Thursday. The filing, submitted in March, was approved under the FDA's Real-Time Oncology Review pilot programme.

The decision was supported by data from the Phase III MAIA study, which demonstrated that the addition of Darzalex to Revlimid plus dexamethasone significantly reduced the risk of disease progression or death by 44 percent compared to treatment with Revlimid and dexamethasone alone.

"The combination of [Revlimid] and dexamethasone is broadly used by newly diagnosed patients with multiple myeloma ineligible for ASCT in the US," said Genmab CEO Jan van de Winkel, adding "we are extremely pleased that physicians can now offer their patients the option to add Darzalex to this regimen in the US."

Darzalex was initially approved in the US in 2015 for patients with multiple myeloma who received at least three prior treatments. The CD38 antibody was later cleared for use in combination with Revlimid and dexamethasone, or Takeda's Velcade (bortezomib) and dexamethasone, for patients who have received at least one prior medicine to treat multiple myeloma. It was also expanded last year in combination with Velcade, melphalan and prednisone, for use in patients with newly diagnosed multiple myeloma who are ineligible for ASCT. Darzalex sales climbed by nearly 46% year-on-year to $629 million in the first quarter.

Johnson & Johnson and Genmab entered into a partnership to co-develop Darzalex in 2012. Earlier this month, the drugmakers inked a separate agreement to jointly develop and commercialise HexaBody-CD38, with van de Winkel saying the next-generation CD38 antibody "could be superior to" Darzalex for certain tumour types and may "extend the promise of CD38-targeted therapies for more patients with multiple myeloma, lymphoma, leukaemia and potentially beyond."  

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